Balloon and manufacture thereof

• US 4,490,421 A
• Filed: 07/05/1983
• Issued: 12/25/1984
• Est. Priority Date: 07/05/1983
• Status: Expired

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: E. I. du Pont de Nemours and Company (Corteva, Inc.)
• Inventors: Levy, Stanley B.
• Primary Examiner(s): Kittle, John E.
• Assistant Examiner(s): Seidleck, James J.
• Application Number:
  US06/510,812
• Time in Patent Office: 539 Days
• Field of Search: 128/344, 128/325, 604/96-103, 428/35, 156/244.13, 156/294, 264/573
• US Class Current: 428/36.9
• CPC Class Codes: A61M 25/1029 Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
• CPC Class Codes: Y10T 428/139 Open-ended, self-supporting conduit, cylinder, or tube-type article
• CPC Class Codes: Y10T 428/1397 Single layer [continuous layer]

Abstract

Polymeric balloon having a burst pressure of at least 200 psi (1.4 MPa) and a radial expansion beyond nominal inflated diameter of less than 5% at 200 psi (1.4 MPa).

Claims

1. High molecular weight, biaxially oriented, flexible polymeric balloon having a burst pressure of at least 200 psi (1.4 MPa) and a radial expansion of less than 5% at 200 psi (1.4 MPa).

2. Balloon of claim 1 having a burst pressure of at least 400 psi (2.8 MPa) and a radial expansion of less than 10% at 400 psi (2.8 MPa).

3. Balloon of claim 1 having a burst pressure of at least 500 psi (3.4 MPa) and a radial expansion of less than 10% at 500 psi (3.4 MPa).

4. Balloon of claim 3 wherein the polymer is a polyethylene terephthalate homopolyester having an intrinsic viscosity of 0.8 to 1.1.

12. Dilatation balloon catheter comprising the balloon of claim 1.

5. Process for forming a high molecular weight, biaxially oriented, flexible polymeric balloon, the process comprising, at a temperature within the range extending from the second order transition temperature to the first order transition temperature, drawing a polymeric tubing having a finite length (L₁) and an internal diameter (ID) which is about one-half the outer diameter (OD) to a length (L₂) which is 3 to 6 L₁, and thereafter expanding the drawn tubing of internal diameter ID₁ and outer diameter OD₁ by expanding means to an internal diameter (ID₂) which is 6 to 8 ID and an outer diameter (OD₂) which is about 3 to 4 OD, followed by cooling the drawn and expanded tubing to less than its second order transition temperature, said balloon thus formed having a burst pressure of at least 200 psi (1.4 MPa) and a radial expansion beyond nominal inflated diameter of less than 5% at 200 psi (1.4 MPa).

6. Process of claim 5 wherein the expanding means is pressurized fluid applied to the inside of the tubing.

7. Process of claim 6 wherein the pressurized fluid is a pressurized gas.

8. Process of claim 5 wherein the tubing is formed by extrusion of polyethylene terephthalate homopolyester resin having an intrinsic viscosity of 1.0 to 1.3 and a density of 1.35 to 1.45 and the balloon has a burst pressure of at least 400 psi (2.8 MPa).

9. Process of claim 8 wherein the temperature is in the range 84°

-99°

C.

10. Process of claim 8 wherein the temperature is in the range 86°

-96°

C.

11. Process of claim 8 wherein the tubing drawing temperature is different from the tubing expanding temperature.